UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010976 |
|---|---|
| Receipt number | R000012846 |
| Scientific Title | Evaluation of efficucy and safety of newly developed capsule endoscope and software. |
| Date of disclosure of the study information | 2013/07/10 |
| Last modified on | 2015/06/15 09:26:12 |
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Basic information
Public title
Evaluation of efficucy and safety of newly developed capsule endoscope and software.
Acronym
Evaluation of efficucy and safety of newly developed capsule endoscope and software.
Scientific Title
Evaluation of efficucy and safety of newly developed capsule endoscope and software.
Scientific Title:Acronym
Evaluation of efficucy and safety of newly developed capsule endoscope and software.
Region
| Japan |
Condition
Condition
Small bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficucy of capsule endoscopy software.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity of the capsule endoscopy software to detect small bowel lesions.
Key secondary outcomes
Reading time of the capsule video.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Reading a capsule video by using newly developed software.
Interventions/Control_2
Reading a capsule video by using conventional software.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have small bowel disease.
Key exclusion criteria
Contraindications for small bowel capsule.(Rey JF, et al. European society of gastrointestinal endoscopy (ESGE). video capsule endoscopy: Update to guidelines (may 2006). Endoscopy. 2006; 38: 1047-1053.)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiko Ogata |
Organization
Keio University
Division name
Center for Diagnostic therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
hogata@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Hosoe |
Organization
Keio University
Division name
Center for Diagnostic therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
hosenao@db3.so-net.ne.jp
Sponsor or person
Institute
Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio university and participating institutions.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keio university and participating institutions.
Name of secondary funder(s)
Olympus medicalsystems CO,LTD.
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 15 | Day |
Last modified on
| 2015 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012846
